Labcorp today announced the nationwide availability of ColoSense, which it said is the only RNA-based at-home test for colorectal cancer (CRC) screening approved by the FDA.
Offered through a commercial collaboration with test developer Geneoscopy, ColoSense expands Labcorp's portfolio of colorectal cancer screening solutions. The test is now covered for eligible Medicare and Medicare Advantage beneficiariesi following the Centers for Medicare & Medicaid Services (CMS) update to the National Coverage Determination (NCD) in June, with additional commercial coverage also available.
ColoSense uses RNA-based technology to detect biomarkers associated with both colorectal cancer and advanced adenomas, precancerous changes that may be an early indication of disease. ColoSense received Breakthrough Device Designation from the FDA, which is reserved for medical devices that offer the potential for more effective diagnosis or treatment of life-threatening conditions. ColoSense aligns with stool-based RNA screening approaches recognized in the American Cancer Society (ACS) colorectal cancer screening guidelines and is included as a recommended screening option in the National Comprehensive Cancer Network (NCCN) guidelines.
ColoSense is available through healthcare providers for adults aged 45 to 85 at average risk and is not for individuals with a history of colorectal cancer or certain high-risk conditions.
Once ordered, the collection kit is delivered directly to the consumer's home for collection and return, featuring a design that eliminates the need to separate or mix the stool sample. Geneoscopy offers patient navigation support to help individuals understand their results and follow recommended next steps, including colonoscopy after a positive result. ColoSense is a screening test and does not replace diagnostic colonoscopy.
